Recruiting

Magnesium Prophylaxis

Sponsor:

Dr. Stephanie Sibley

Code:

NCT05829317

Conditions

Critical Illness

New Onset Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnesium sulfate

Placebo

Study Details

Brief summary:

A double-blind, multi-centre, randomized, placebo-controlled, feasibility pilot trial in the prevention of new onset atrial fibrillation of critically ill patients admitted to an ICU.

Conditions

Critical Illness

New Onset Atrial Fibrillation

Study ID

NCT05829317

Start date

Aug 20, 2023

Status verified date

Sep, 2025

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

1. Age ≥18 years;
2. Admitted to an ICU with one or more of the following:

1. Non-invasive ventilation (including CPAP, Bipap and high flow oxygen (>10L/min) or invasive mechanical ventilation with an expected duration >24 hours for respiratory failure (hypercarbic or hypoxic)
2. Vasopressor or inotropic support with an expected duration of >24 hours
3. Cardiac arrest
3. Continuous cardiac monitoring.

Exclusion Criteria

1. Receiving ICU intervention (Non-invasive ventilation (including high flow nasal canula), invasive mechanical ventilation or inotropic support) for >18 hours
2. Receiving IMV for airway protection only (for example, isolated head trauma)
3. Active atrial fibrillation at the time of enrolment
4. On oral or continuous infusion of Amiodarone
5. Unlikely to survive >24 hours or palliative patients
6. Cardiac surgery patients
7. Patients requiring parenteral magnesium therapy (e.g. pre-eclampsia, asthma)
8. Patients receiving dialysis
9. Positive pregnancy test (females <50 years old)
10. Previously enrolled in this trial
11. Treating physician refuses enrollment

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Magnesium Sulfate

4g Magnesium sulfate (100mL) BID, given intravenously over 2 hours, for a total of 10 doses

placebo comparator: 0.9% NaCl

100mL 0.9% NaCl BID, given intravenously over 2 hours, for a total of 10 doses

Interventions

Magnesium sulfate

Intravenous Magnesium sulfate

Placebo

0.9% NaCl

Primary outcome measure

  • RCT Feasibility [ Time Frame: 90 days ]
  • RCT Feasibility [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Locations

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L2V7

Contacts

Principal Investigator:

Stephanie Sibley, MD

More Information

Sponsor

Dr. Stephanie Sibley

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

  • Prophylaxis
  • Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Stephanie Sibley on 2025-09-22.